DrugJun 7, 2023
Akorn Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials recall — FDA D-0825-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 93
Records are ordered by the best available source date.
DrugJun 7, 2023
Akorn AK-POLY-BAC recall — FDA D-0788-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye recall — FDA D-0779-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial recall — FDA D-0863-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous recall — FDA D-0802-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Rifampin Capsules USP, 300 mg recall — FDA D-0841-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes recall — FDA D-0795-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles recall — FDA D-0860-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only recall — FDA D-0785-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ferrous Sulfate Iron Supplement Drops recall — FDA D-0803-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles recall — FDA D-0827-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes recall — FDA D-0821-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes recall — FDA D-0786-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles recall — FDA D-0792-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recall — FDA D-0787-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Denison Pharmaceuticals Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm recall — FDA D-0774-2023
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class IIFDA: OngoingDenison Pharmaceuticals, LLC
DrugJun 7, 2023
Akorn Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles recall — FDA D-0864-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Cream, USP, 0.05% recall — FDA D-0794-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion recall — FDA D-0818-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
VehicleJun 7, 2023
Sportage power assist recall — NHTSA campaign 23V410000
Kia America, Inc. (Kia) is recalling certain 2023 Sportage vehicles. The brake booster diaphragm may become misaligned and cause an internal vacuum leak, which can result in a loss of power…
power assistKia America, Inc.
VehicleJun 1, 2023
Ascent lower arm recall — NHTSA campaign 23V392000
Subaru of America, Inc. (Subaru) is recalling certain 2023 Ascent vehicles. The left or right front lower control arm may have an improperly tightened ball joint castle nut which can result…
lower armSubaru of America, Inc.
Medical DeviceMay 31, 2023
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia recall — FDA Z-1626-2023
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or…
Class IIFDA: OngoingBinx Health, Inc.
Medical DeviceMay 31, 2023
Siemens Medical Solutions USA LUMINOS Lotus Max (VF11) recall — FDA Z-1481-2023
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 31, 2023
Windstone Medical Packaging Aligned Medical Solutions Spine Pack, REF: AMS4599 recall — FDA Z-1619-2023
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.